In the cleanroom industry, there are many different quality standards that both manufacturers and facilities managers must be aware of and comply with. We’ve already discussed ISO standards and Federal 209E standards, even USP standards — but one we haven’t discussed much is GMP standards.
Let’s explore what GMP standards are, what they entail, who needs to comply with them, and more.
GMP stands for Good Manufacturing Practices, which is a quality management system used mainly by medical and pharmaceutical manufacturers to ensure a controlled cleanroom environment. In the United States, GMP standards are established and enforced by the Food & Drug Administration (FDA), but in other countries they’re controlled by different regulatory bodies.
Although it’s important to be aware of minor differences across the globe, the main goal of GMP standards remains the same: to minimize the risks of microbiological, particulate, and pyrogen contamination during preparation and sterilization of medicines or medical devices. This helps ensure that products are of consistent high quality, are appropriate for their intended use, and meet the requirements of product specifications.
In order to ensure this level of control, GMP standards address cleanroom issues like:
GMP standards are different from other cleanroom quality standards, but none of them are mutually exclusive. Some cleanrooms need to meet multiple sets of standards in order to be fully controlled and compliant.
For the sake of brevity, we won’t discuss every type of cleanroom quality standard. Instead, we’ll focus mainly on how GMP standards are different from ISO standards since they’re the most common.
The biggest difference between GMP standards and ISO standards is that GMP standards are mainly used in medical applications. ISO standards, on the other hand, are commonly used in a diverse range of industries, from medical to automotive, plastic injection molding, and more.
Another difference between these two standard sets is that ISO standards distinguish nine “classes,” while GMP standards distinguish four “grades.” Here’s an overview of the four GMP grades:
If you’d like a more detailed description of GMP/ISO equivalents, check out these cleanroom classification comparison tables from our partners at Connect 2 Cleanrooms (C2C).
As mentioned above, GMP standards are mostly used in medical and pharmaceutical cleanrooms. Any application that involves producing, filling, compounding, or packaging sterile medicinal products needs to comply with GMP standards. This could include cleanroom industries and applications like:
If you’re unsure if your cleanroom must comply with GMP standards, it’s best to consult with a cleanroom design and installation professional. They’ll be able to tell you which quality standards your space must be designed to accommodate.
Qualification and validation is a critical component of GMP standards. These protocols help provide documented evidence that your cleanroom meets a high level of control, is compliant with all applicable standards, and will consistently yield high-quality products. GMP guidance calls for the following four stages of qualification and validation:
At first glance, this may seem like a lot of qualification stages to go through — and it can be! GMP qualification and validation requires a significant amount of effort, but it must be done before you can begin operations. If you’re looking to streamline the process, a reputable and experienced cleanroom manufacturer can support you.
Want to see a GMP cleanroom project in action? Recently, our partners at C2C completed a GMP-compliant cleanroom suite for cell and gene therapy client RoslinCT.
The cleanroom suite consisted of 33 different rooms, the breakdown being:
The large facility obtained full GMP qualification and now operates according to both US and EU GMP standards — ensuring consistent, high-quality results in the rapidly growing, life-saving field of cell and gene therapy.
If you’d like to learn more about this GMP cleanroom project, you can find the full project description here.
Have questions about GMP standards and how they relate to your cleanroom design? Get in touch with our team at Angstrom Technology. As cleanroom design and installation experts, we’re happy to guide you through the GMP qualification and validation process and to ensure your cleanroom is built for safe, controlled operations.
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